Class 2 Device Recall Monaco

• Date Initiated by Firm: September 29, 2016
• Create Date: October 13, 2016
• Recall Status: Terminated on July 16, 2021
• Recall Number: Z-0076-2017
• Recall Event ID: 75303
• 510(K)Number: K151233
• Product Classification: System,planning,radiation therapy treatment - Product Code MUJ
• Product: Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distribution inside patients for given treatment plan set-ups
• Code Information: Software Builds 5.10 and 5.20
• Recalling Firm/ Manufacturer: Elekta, Inc.; 400 Perimeter Center Ter NE Ste 50; Atlanta GA 30346-1227
• For Additional Information Contact: Joseph Carter; 770-670-2422
• Manufacturer Reason for Recall: When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly.
• FDA Determined Cause: Device Design
• Action: Elekta sent an Important Field Safety Notice 382-01-MON-005 was sent to all affected customers on 9/29/2016. The notice informs users of the specific product and version numbers affected by the issue,and any work arounds that can be used to avoid the issue. The notice included an acknowledgment form which is to be returned. For questions regarding this recall call 314-993-0003 or 800-878-4287.
• Quantity in Commerce: 365
• Distribution: Worldwide Distribution - US to CA, FL, KY, MD, MO, MT, NJ, NC, PA, WA, WI. Internationally to Algeria. Antiqua & Barbuda, Argentina, Australia, Austria, Belarus, Botswana, Brazil, Bulgaria, China, Columbia, Croatia, Czech Republic, Ecuador Estonia, France, Germany, India, Iran, Israel, Italy, Japan, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Portugal, Romania, Russia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Zimbabwe.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MUJ